Status:
RECRUITING
Intestinal Dysbiosis and BBB Integrity in Autism
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
LBPC, Inserm 1183, IRMB CHU Montpellier
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
Autism Spectrum Disorder (ASD) is characterised by an impairment of social interactions and communication, associated with repetitive behaviour and restrictive interests. Clinical phenotypes of this n...
Detailed Description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by impaired social interactions and communication, associated with repetitive behaviors and restricted interests. The path...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Child from the ELENA cohort who received at least 3 years of follow-up in this cohort and a diagnosis of ASD
- Aged 6 to 16 years
- Living in Languedoc-Roussillon
- Consent to participate in the study signed by the legal representative
- Exclusion criteria:
- Syndromic autism (neuroanatomical abnormality detected on brain MRI, severe neurological syndrome or polymalformative)
- Known severe gastrointestinal pathology (such as celiac disease or Crohn's disease)
- Other known severe chronic disease (e.g., diabetes)
- Specific diet (gluten-free, casein-free, ketogenic, protein-enriched) within 6 months
- Antibiotics taken within 2 months prior to inclusion
- Probiotics taken in the 6 months prior to inclusion
- Oxytocin intake in the 6 months prior to inclusion
- ADOS Level Module 4 (due to the impossibility of calculating a ADOS-CSS score in this case)
- Not affiliated to a French social security scheme or not beneficiaries of such a scheme
- Refusal of blood test
- Pregnant women
Exclusion
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04321915
Start Date
April 26 2021
End Date
February 26 2025
Last Update
May 29 2024
Active Locations (1)
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1
Centre de Ressources Autisme
Montpellier, France, 34295